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FDA 510(k)

AESCULAP MONOMAX ABSORBABLE SUTURE

K-Number: K100876 · 2010-07-14

ApplicantAesculap, Inc.
Decision Date2010-07-14
Product CodeNWJ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AESCULAP MONOMAX ABSORBABLE SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2010-07-14 under 510(k) number K100876. The device is classified under product code NWJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AESCULAP MONOMAX ABSORBABLE SUTURE?

AESCULAP MONOMAX ABSORBABLE SUTURE is a medical device that received FDA 510(k) clearance on 2010-07-14. The listed applicant is Aesculap, Inc.. The 510(k) number is K100876.

When did AESCULAP MONOMAX ABSORBABLE SUTURE receive FDA 510(k) clearance?

AESCULAP MONOMAX ABSORBABLE SUTURE received FDA 510(k) clearance on 2010-07-14, under 510(k) number K100876.

Who is the listed applicant for AESCULAP MONOMAX ABSORBABLE SUTURE?

The FDA 510(k) record lists Aesculap, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AESCULAP MONOMAX ABSORBABLE SUTURE?

The FDA product code for AESCULAP MONOMAX ABSORBABLE SUTURE is NWJ.

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Other records listing Aesculap, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242762Aesculap Aicon® Series Container SystemK242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetK223596SQ.line KERRISONK214041Aesculap AICON ContainerK211572Aesculap Slim Clip ApplierK203739ELAN 4 Electro Motor System

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Related Devices (Code: NWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211307GalaSTITCH Absorbable Monofilament SutureTepha, Inc.K132348TEPHAFLEX BRAIDED SUTURETepha, Inc.K130422PHANTOM FIBER BIOFIBER SUTURETornier, Inc.K122487BIOFIBER SYTURETornier, Inc.K082178TEPHAFLEX ABSORBABLE SUTURETepha, Inc.K081099TEPHAFLEX ABSORBABLE SUTURETepha, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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